D-0863-2026 Class II Ongoing
FDA drug recall D-0863-2026 was initiated by Sterling Pharmaceutical Services LLC on Aug 20, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 107,377 packs.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 107,377 packs
Product Description
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
USA Nationwide
Code Information
Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027